A new study finds that the majority of research institute review board members and other research ethics professionals are ethically concerned about the effects of offering money as an incentive for healthy volunteers to enroll in research studies. The participants in the study, however, differed in their views of the meaning of coercion and undue influence and how to avoid these problems in concrete research situations.
The study appears in IRB: Ethics and Human Research.
According to the study’s authors, the findings are important because the federal regulations for the protection of human subjects—known a the Common Rule—state that investigators should seek consent from potential research volunteers under circumstances that “minimize the possibility of coercion or undue influence.” The regulations do not define these terms.
The study consisted of an online survey that asked a random sample of IRB members about their views on different kinds of payments, including nonmonetary offers, and medical care. Of the 610 respondents, 61% “reported feeling somewhat, moderately, or very concerned that payment of any amount might influence a participant’s decision or behaviors regarding research participation.” The higher the payment, the greater the concern.
Among the respondents, 85% expressed concern that substantial payment could compromise a participant’s ability to think clearly about a study’s risks and benefits. While 88% of respondents worried that such a payment could lead individuals to enroll in a trial they otherwise would not enroll in, 84% expressed concern that individuals would remain in a study from which they would like to withdraw.
Most respondents agreed that researchers could offer money to reimburse expenses, and many thought that offering money as compensation for time and inconvenience was acceptable. The authors, however, concluded that the respondents’ views of coercion and undue influence were “excessively expansive, or inconsistent.” For example, while more than 90% agreed with a definition of coercion tied to threat of harm, most agreed that research participants are coerced when an offer of payment—not the threat of harm—gets them to participate when they otherwise would not.
The findings pose a dilemma to those charged with ethical oversight of human-subjects research. According to the authors, unless researchers can offer payment as an incentive to participate in research, people might not enroll in studies and, therefore, much valuable research “is unlikely to be conducted in a timely manner or even conducted at all.” And yet, the say, institutional review boards should not approve protocols—whatever their social or scientific value—unless the possibility of coercion or undue influence has been minimized. To get around this dilemma, the authors recommend that policy and educational efforts be undertaken to clarify when payment practices actually constitute coercion and undue influence.
Source: The Hastings Center
